Catalog Number 284002 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Abdominal Distention (2601)
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Event Date 09/10/2015 |
Event Type
Injury
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Manufacturer Narrative
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Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.
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Event Description
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It was reported by the sales rep that they were getting a lot of distention during use.No additional information was known.Additional information received via phone by mitek complaints on (b)(6) 2015: the sales rep reported that during a shoulder procedure that the fms vue pump was not functioning correctly and caused extravasation in the shoulder area.He reported that the visibility was reduced causing the procedure to be extended by 15 minutes.The sales rep reported that the area was manually decompressed to reduce the fluid buildup and that the patient was fine post-op and allowed to go home as planned.
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Manufacturer Narrative
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The pump was received at the repair center and tested.The pump failed the occlusive test.The springs on pressure arm housings and the plungers were replaced to correct issue.The root cause of this failure is a worn spring and plunger.The unit passed all diagnostic tests, functional tests, and is fully operational.This complaint can be confirmed.A review into the depuy mitek complaints system revealed no other complaints of any type for the serial number of this device.At this point in time, no further action is warranted.However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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Event Description
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It was reported by the sales rep that they were getting a lot of distention during use.No additional information was known.Additional information received via phone by mitek complaints on (b)(6) 2015: the sales rep reported that during a shoulder procedure that the fms vue pump was not functioning correctly and caused extravasation in the shoulder area.He reported that the visibility was reduced causing the procedure to be extended by 15 minutes.The sales rep reported that the area was manually decompressed to reduce the fluid buildup and that the patient was fine post-op and allowed to go home as planned.
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Search Alerts/Recalls
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